Z-0617-2025 Class II Ongoing
FDA device recall Z-0617-2025 was initiated by Advanced Medical Solutions Ltd. on October 1, 2024 and is designated Class II. Reason for recall: Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. The recall status is ongoing. Affected quantity: 3900 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2024
- Initiation Date
- October 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3900 boxes
Product Description
Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: ¿ pressure ulcers ¿ leg ulcers ¿ cavity wounds ¿ lacerations ¿ post-operative surgical wounds
Reason for Recall
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Distribution Pattern
U.S. Nationwide distribution in the states of IL, TX, and VA.
Code Information
Model Number: 529937R UDI-DI code: 0060075029530 Lot Number: W00070134